Uzbekistan’s healthcare market is growing, and so is the demand for safe, high-quality medical devices. But before your product can reach hospitals, clinics, or patients, it must be placed in the right regulatory class. This classification determines how your device will be reviewed, the documents required, and how long approval will take.
If you’re a manufacturer or distributor looking to enter Uzbekistan, understanding the classification system is your first step toward compliance — and success.
Uzbekistan’s Medical Device Classification System
Before diving into the specific categories, let’s first understand the overall framework of Uzbekistan’s medical device classification system and why it plays such a critical role in the approval process.
How Uzbekistan Classifies Medical Devices
The system is risk-based and similar to the EU model. The higher the potential risk to the patient, the stricter the requirements.
- Class I – Low-risk devices
Example: non-sterile bandages, manual surgical instruments.
- Class IIa – Medium-risk, short-term contact devices
Example: diagnostic ultrasound, infusion pumps.
- Class IIb – Medium to high risk
Example: anesthesia equipment, contact lenses.
- Class III – High-risk devices
Example: cardiac stents, pacemakers, implantable defibrillators.
Why it matters:
Your classification impacts the application process, testing, labelling, and timelines. Getting it wrong can delay market entry or lead to rejection.
Registration Pathways in Uzbekistan
Once classification is confirmed, there are two main routes to register your medical device:
1️⃣ Full National Registration
Used when your device does not have prior certification from recognized authorities.
Process:
- Appoint a local Authorized Representative.
- Prepare and submit the dossier, including product samples.
- State Centre conducts technical and clinical evaluations.
- Expert Council reviews and issues a decision.
- Ministry of Health publishes the order.
- Registration certificate issued.
Timelines:
- Class I – Around 6 months
- Class IIa / IIb – 6–9 months
- Class III – 9–12 months
Registration is valid for 5 years.
2️⃣ Simplified/Recognition Route
If your device already has approval from FDA, CE Mark, MHRA, PMDA, or MFDS, you may qualify for the fast-track process.
Timeline:
Medium and high-risk devices can be approved in as little as 15 working days under this pathway.
Digital Labelling Requirements
Since 2022, Uzbekistan mandates GS1 DataMatrix codes on medical devices for traceability. Labels must include:
- GTIN
- Serial number
- Crypto key and code
Key deadlines:
- By Feb 1, 2025: Serialization required.
- By Nov 1, 2025: Aggregation for packaging layers.
Failing to meet these requirements can result in import restrictions.
Special Exemptions
Some devices are exempt from full registration if:
- No local equivalent exists.
- They are listed in the Ministry-approved exemption list.
In such cases, only certification is required.
Why Work with OMC Medical
When it comes to medical device registration in Uzbekistan, choosing the right partner can make or break your market entry.
OMC Medical offers:
- Local Presence & Representation – We act as your official Authorized Representative, ensuring your submissions meet Uzbekistan’s specific requirements.
- Full Regulatory Management – From classification to dossier preparation, translations (Uzbek & Russian), and Ministry submissions.
- Faster Market Entry – We identify when you can use simplified pathways, cutting approval times from months to weeks.
- End-to-End Compliance – We make sure your labelling, packaging, and documentation meet GS1 and digital marking requirements.
- Global Expertise, Local Knowledge – Our ISO-certified team brings international regulatory experience tailored to Uzbekistan’s rules.
✅ With OMC Medical, you’re not just submitting documents — you’re gaining a strategic partner focused on getting your product approved and into the market quickly and compliantly.
Final Thoughts
Whether you’re launching a Class I diagnostic tool or a Class III life-saving device, the right classification and registration strategy can make all the difference.
OMC Medical has the expertise, local network, and global regulatory knowledge to make your Uzbekistan market entry smooth and successful.
📞 Contact us today to get started.
